Download - Navigating Research in Pediatric Populations
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Navigating Research in Pediatric Populations
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Accredited
• Fully Accredited by the Association for Accreditation of Human Research Protection Programs (AAHRPP) through 2014
• Fully compliant with FDA and OHRP requirements
International capabilities
• Boards available for the review of US and Canadian Studies
Strong Framework
• Approx. 200 employees – one of the largest IRBs in the US
Certified IRB Professionals (CIP)
• 60% of Affiliated IRB members, 40% of Regulatory staff and 20% of study management & study support positions
About Quorum Review IRB
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• 13 Board meetings each week
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and same day site changes
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The Quorum Advantage
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approval documents
• Customized Phase I and Post-Marketing processes
• Flexible, customized process for AMCs
• 100% Quality Control on all documents
The Quorum Advantage
8
Regulatory Attorney
Mitchell Parrish, JD, CIP
IRB Experience • Joined Quorum Review IRB in January 2010
• Regulatory Counsel with WIRB prior to Quorum
• Former Regulatory Advisor to the National Cancer Institute Central IRB
• CIP certified
Legal Background • Juris Doctor from the University of Oregon School of Law
• Member of the Washington State and American Bar Associations
• Member of the Health and Corporate Law Sections of the WSBA
About the Presenter
9
Importance of Research in Pediatric Populations 11
Regulatory Landscape 21
Research Permitted in Pediatric Populations 24
Recruiting Pediatric Populations 32
Consenting Pediatric Populations 40
Conducting Research in Pediatric Populations 64
Key Take Aways 74
Webinar Overview Description of Topic Page
10
Importance of Research in
Pediatric Populations
Importance of Research in Pediatric Populations
The evolving view of children in research has changed from protecting children from research to protecting children through research
12
Old View Protect children from research
• Result = Children not subjected to the potential harm from research
• End Result = A limited number of medical products evaluated for use in children
New View Protect children through research
• Result = Children subjected to potential harm, but such harm is mitigated by ensuring ethically and scientifically sound research that includes additional protections
• End Result = The development of medical products appropriately evaluated for use in children
Importance of Research in Pediatric Populations
13
Without medical products approved for children, certain harms may occur:
Denial of a potential treatment
o Physicians refusing to use a drug or device approved for adults “off label”
The wrong dose
o Dose too high (harmful) (Ex. Use of the Antibiotic Chloramphenicol in the 1950s)
o Dose too low (ineffective)
Importance of Research in Pediatric Populations
Supporting the New View Why it’s necessary to develop medical products evaluated for children
14
Children are not small adults. Simply adjusting a drug’s dose or
modifying a device according to a child’s weight is not always
sufficient or appropriate due to additional considerations:
o dynamics of growth
o maturation of organs
o changes in metabolism throughout infancy and childhood
o changes in body proportion
o other developmental changes that affect how drugs are
metabolized
Importance of Research in Pediatric Populations
Supporting the New View Why it’s necessary to develop medical products evaluated for children
15
Drugs may behave in a qualitatively different manner based on
age. There may also be quantitative differences including:
o dose-response relationships
o pharmacokinetic parameters
o magnitude of effect
o risk of an adverse event
o other variables that require defining based on the study population
Basing conclusions on the effects observed in adults is not always
useful, or feasible, because responses in pediatric patients may be
different from those reported in adults
Importance of Research in Pediatric Populations
Supporting the New View Why it’s necessary to develop medical products evaluated for children
16
• Potential harms
• Children are not small adults
• Products behave qualitatively and quantitatively based on age
Therefore, medicinal products should be studied in children who
are representative of the range of patients likely to receive the
product once it’s marketed
Importance of Research in Pediatric Populations
Supporting the New View Why it’s necessary to develop medical products evaluated for children
17
• Ibuprofen: Studies in infants established safe and effective dosing information for children ages 6 months to 2 years
• Zantac (ranitidine): Studies in infants established accurate dosing information for safer and more effective use of the drug to manage gastroesophageal reflux in seriously ill infants
• Claritin (loratadine) syrup: Treats allergies and hives. Studies established that patients ages 2 to 5 require a lower dose compared to older children and adolescents
Importance of Research in Pediatric Populations
Examples of demonstrated SUCCESS in conducting research in children: Changing Drug Labels
FDA Web Article, Drug Research in Children
18
• Pepcid (famotidine) tablets, capsules, and oral solution:
Studies revealed patients up to 3 months require a lower dose
to treat gastroesophageal reflux disease because their ability to
get rid of drug is less than that of older children and adults
• Midazolam hydrochloride syrup and injection: Used as a
sedative. Studies showed a higher risk of serious and life-
threatening adverse events for children with congenital heart
disease and pulmonary hypertension and identified the need to
begin therapy with doses at the lower end of the dosing range to
prevent respiratory problems in pediatric populations
Importance of Research in Pediatric Populations
FDA Web Article, Drug Research in Children
Examples of demonstrated SUCCESS in conducting research in children: Changing Drug Labels
19
• While products specifically evaluated in children will
help protect children, there are undoubtedly still
risks from participating in research
• To mitigate these risks, all parties (sponsor, CROs,
investigators, research staff, IRB) must ensure
research is ethically and scientifically sound
Importance of Research in Pediatric Populations
Supporting the New View Ethically and Scientifically Sound Research
20
Regulatory Landscape
FDA 21 CFR 50 (Protection of Human Subjects)
• Subpart D – Additional Safeguards for Children in Clinical Investigations
21 CFR 56 (Institutional Review Boards)
FDASIA (FDA Safety and Innovation Act, title V)
FDAAA (FDA Amendments Act of 2007, Pediatric Tracking Requirements)
PREA (Pediatric Research Equity Act of 2007)
BPCA (Best Pharmaceuticals for Children Act of 2007)
DHHS 45 CFR 46 (Protection of Human Subjects)
• Subpart D – Additional Protections for Children Involved as Subjects in Research
Regulatory Landscape United States
22
• Tri-Council Policy Statement (TCPS 2) (Ethical Conduct for Research Involving Humans)
• ICH-E11 (Clinical Investigation of Medicinal Products in the Pediatric Population)
• Health Canada Addendum to the ICH-E11
Regulatory Landscape Canada
23
Research Permitted in Pediatric Populations
IRBs may only APPROVE research in children that falls into one of
the following four categories:
1. Research not involving greater than minimal risk (21 CFR 50.51/ 45 CFR 46.404 )
o Permission of parent/guardian and assent of participant
2. Research involving greater than minimal risk but presenting the
prospect of direct benefit to individual participants (21 CFR 50.52/ 45 CFR 46.405 )
o Risk is justified by the anticipated benefit to participant
o Risk to benefit is at least as favorable to participant as available
alternatives
o Permission of parent/guardian and assent of participant
Definition of Minimal Risk = the probability and magnitude of harm or discomfort anticipated in
the research are not greater in and of themselves than those ordinarily encountered in daily life
or during the performance of routine physical or psychological examinations or tests
Research Permitted in Pediatric Populations
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3. Research involving greater than minimal risk and no prospect of
direct benefit to individual subject, but likely to yield generalizable
knowledge about the subjects’ disorder or condition (21 CFR 50.53/ 45 CFR 46.406 )
o The risk represents a minor increase over minimal risk
o Study presents experiences that are similar to actual non-research medical,
dental, psychological, social, or educational situations
o Study is likely to yield generalizable knowledge about the participant’s
disorder or condition that is vital to understanding or ameliorating the
disorder or condition
o Permission of both parents/guardians and assent of participant
Note: To enroll a “ward” research must be 1) related to child’s status as a ward or
conducted in setting where majority of children are not wards (schools, hospitals)
and 2) each ward must have an advocate
Research Permitted in Pediatric Populations
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4. Research not otherwise approvable that presents an opportunity to
understand, prevent, or alleviate a serious problem affecting the
health or welfare of children (21 CFR 50.54/45 CFR 46.407)
Research Permitted in Pediatric Populations
IRB may not approve unless
27
IRB finds and documents that study will further the understanding,
prevention, or alleviation of a serious problem affecting children
The DHHS Secretary or FDA Commissioner in consultation with a
panel of experts and following opportunity for public review and
comment, determines:
o the study presents an opportunity to further the understanding,
prevention, or alleviation of a serious problem affecting children
o the study will occur with sound ethical principles, and
o There are adequate provisions for obtaining both
parents/guardians permission and participant assent
Note: To enroll a “ward” research must be 1) related to child’s status as a ward or
conducted in setting where majority of children are not wards (schools, hospitals)
and 2) each ward must have an advocate
Research Permitted in Pediatric Populations
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Research Permitted in Pediatric Populations
Testing Our Knowledge
A survey study is being conducted to record statistics on illicit drug use in
middle school and high school students. As part of the research, students
are asked to complete a series of questions regarding their drug use, if
any, and are asked to sign and date the questionnaire.
Assuming the study is likely to yield generalizable knowledge about
underage drug use and addiction, which regulatory category
applies?
29
Research Permitted in Pediatric Populations
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A. 21 CFR 50.51/45 CFR 46.404 \ Research not involving greater than minimal risk
B. 21 CFR 50.52/45 CFR 46.405 \ Research involving greater than minimal risk but
presenting the prospect of direct benefit to individual participants
C. 21 CFR 50.53/ 45 CFR 46.406 \ Research involving greater than minimal risk
and no prospect of direct benefit to individual subject, but likely to yield
generalizable knowledge about the subjects’ disorder or condition
D. 21 CFR 50.54/45 CFR 46.407 \ Research not otherwise approvable that
presents an opportunity to understand, prevent, or alleviate a serious problem
affecting the health or welfare of children
Research Permitted in Pediatric Populations
Answer:
31
C. 21 CFR 50.53/ 45 CFR 46.406 \ Research involving greater than
minimal risk and no prospect of direct benefit to individual subject,
but likely to yield generalizable knowledge about the subjects’
disorder or condition
Recruiting Pediatric Populations
Recruiting activities are the beginning of
the informed consent process
Recruiting Pediatric Populations
Recruiting Study Subjects – Information Sheet:
Guidance for Institutional Review Boards and Clinical Investigators Most applicable guidance in knowing what to consider when advertising to or recruiting children
33
Based on FDA guidance, the IRB needs
to review advertising and recruitment to
ensure advertisements to children:
• Are not unduly coercive
• Do not promise or imply a favorable outcome or other
benefits beyond what is contained in the protocol
• Do not communicate that the study product is safe or
effective for the purposes under investigation
Recruiting Pediatric Populations
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• Do not make claims that the study product is known to be equivalent or superior to any other study product
• Do not include language indicating that regulatory authorities, such as the FDA and IRB, have approved the research
• Do not cause therapeutic misconception (e.g. modify the word “treatment” or “medicine” with a word that does not imply a benefit)
Recruiting Pediatric Populations
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• Do not promise or imply free medical treatment when the
intent is only to say subjects will not be charged for
participation in the investigation
• Do not emphasize payment
• Provide information limited to that which subjects need to
determine their eligibility and interest
• Do not include statements that are generally misleading
Recruiting Pediatric Populations
36
Recruiting Pediatric Populations Testing Our Knowledge
A proposed radio advertisement to be played on the local #1 hit music station reads:
Do you suffer from Asthma? Asthma is a chronic disease of the airways that makes
breathing difficult. ABC Health Clinics is conducting a research study to test the
safety and effectiveness of an investigational drug that will cure asthma. If you are
16-22 years old, have asthma, and want $300 to help buy those next concert tickets,
then call 1-800-123-4567 to see if you qualify for the study.
What information in the advertisement would the IRB find most problematic?
37
What information in the advertisement would the IRB find most
problematic?
Recruiting Pediatric Populations
A. “that will cure asthma”
B. “want $300 to help buy those next concert tickets”
C. “test the safety and effectiveness of an investigational
drug”
D. A and B
E. A, B and C
38
Recruiting Pediatric Populations
Answer:
D. A and B
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Consenting Pediatric Populations
To enroll a child into research there must be
permission AND assent
Consenting Pediatric Populations
41
Note: There is a significant difference between having the authority to consent on behalf of a child for medical care versus enrollment in research
Consenting Pediatric Populations
LAR
Parent
Guardian
a child’s biological
or adoptive parent
individual who is
authorized under
applicable state or
local law to consent
on behalf of a child
individual or judicial or other body
authorized under applicable law to
consent on behalf of a child
Who Can Give Permission?
42
Permission Definition: The agreement of
parent(s) or guardian to the
participation of their child or ward in
research [21 CFR 50.3(r)/ 45 CFR 46.402(c)]
In other words: A parent must
provide their consent consistent
with the consent regulations
Therefore, for a child to participate
in research the parent must
generally sign a consent form on
behalf of their child and that
consent form must contain all
applicable consent elements
• Explanation of the research
• Any benefits
• Confidentiality
• Contact information
• Foreseeable risks & discomforts
• Alternative Procedures
• Compensation and Treatment for injuries
• Voluntary participation and no loss of benefits
• Additional elements found at 21 CFR 50.25(b)/ 45 CFR 46.116(b) (e.g. costs)
Consenting Pediatric Populations
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Permission
Consenting Pediatric Populations
One or both Parents/Guardians
1. Research not involving greater than minimal risk
(21 CFR 50.51/ 45 CFR 46.404 )
• One parent/guardian
2. Research involving greater than minimal risk but presenting the
prospect of direct benefit to individual participants
(21 CFR 50.52/ 45 CFR 46.405 )
• One parent/guardian
44
Permission
Consenting Pediatric Populations
One or both Parents/Guardians
3. Research involving greater than minimal risk and no
prospect of direct benefit to individual subject, but likely to
yield generalizable knowledge about the subjects’ disorder
or condition (21 CFR 50.53/ 45 CFR 46.406 )
• Both parents/guardians
4. Research not otherwise approvable that presents an
opportunity to understand, prevent, or alleviate a serious
problem affecting the health or welfare of children (21 CFR
50.54/45 CFR 46.407)
• Both parents/guardians
45
If Permission of both Parents/Guardians is required then . . .
both parents/guardians must give their permission
unless one is deceased, unknown, incompetent, or
not reasonably available, or when only one has legal
responsibility for the care and custody of the child
Consenting Pediatric Populations
46
Consenting Pediatric Populations Testing Our Knowledge
An IRB is reviewing a Phase III study involving an investigational drug for juvenile diabetes. The drug has some potential significant side effects.
47
Consenting Pediatric Populations
Is permission of one or both parents required?
Testing Our Knowledge An IRB is reviewing a Phase III study involving an investigational drug for juvenile diabetes. The drug has some potential significant side effects.
48
Consenting Pediatric Populations
A. One, since the research does not involve greater than minimal risk
B. One, since the research involves greater than minimal risk but presents
the prospect of direct benefit
C. Two, since the research involves greater than minimal risk but presents
the prospect of direct benefit
D. Two, since the IRB determined that while the research presents the
prospect of direct benefit, the drug has potential significant side effects
49
Consenting Pediatric Populations
Answer:
D. Two, since the IRB determined that while the research
presents the prospect of direct benefit, the drug has potential
significant side effects
50
Minor
a person who, under local law, is under the
age of majority. The age of majority is the age
at which the individual is considered an adult.
Generally, minors cannot consent to
participate in research
Child
defined by federal regulations as a person
who has not attained the legal age for consent
to treatments or procedures involved in
research under local law
Ward
a minor who is has a guardian appointed by a
court or governmental agency; in other words,
a minor who is under the temporary custody
or care of the local jurisdiction in which they
reside (e.g. a foster child)
Emancipated Minor
a person who is recognized to have the full
legal rights of an adult under local law even
though he/she is a minor. Minors can become
emancipated through certain actions, such as
marriage, enlistment in the military or living
independently. Emancipation may require a
court order. Emancipated minors may be able
to consent to research depending on local law
Mature Minor
a person who, under local law, may consent
to certain health care treatment or procedures
(such as drug or substance abuse or sexually
transmitted diseases) even though he/she is a
minor. Mature minors may be able to consent
to research depending on local law
Consenting Pediatric Populations Who Must Assent?
51
Consenting Pediatric Populations
Minor
Mature Minor
(consent)
Emancipated
Minor (consent)
Child
(assent)
Ward
(assent)
52
Consenting Pediatric Populations
States that are not “18” – see map
AL
19 MS
21
NE
19
PA
21
Puerto Rico
21
53
Consenting Pediatric Populations
Provinces and Territories in Canada that are not “18” – see map
BC
19
NB
19
NL
19
NT
19
NS
19
NU
19
YT
19
54
Definition:
A child’s affirmative agreement to participate in research
(mere failure to object may not be construed as consent) [21 CFR 50.3/45CFR46.402]
Consenting Pediatric Populations
55
Assent
To determine whether Assent is required,
how to administer assent, and how to
document assent the IRB must consider
• age
• maturity
• psychological state
Consenting Pediatric Populations
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Assent
Waiver of Assent. Requirement for
Waiver 21 CFR 50.55(c)/45 CFR 46.408(a)
1. The capability of some or all of the
children is so limited that they
cannot reasonably be consulted
or
2. the study presents the prospect of
direct benefit that is important to
the health or well-being of the
children and is available only in
the context of research (ex. pediatric
oncology trials)
Consenting Pediatric Populations
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Assent requirements
Based on age
below7
Option 1: Assent form
for ages 7-18 with
reading levels at lowest
age
• participant signs
assent (or assent is
documented in
participant’s chart)
Consenting Pediatric Populations
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Based on age Between
7 and 18
Reminder! • Different ages of majority
• Whenever a participant turns the age of
majority during a study that participant
must be consented with the consent form
Assent requirements
Option 2: Assent Form
for ages 7-11 and 12-18
with reading levels at
the lowest age
• participant signs assent
(or assent is documented
in participant’s chart)
Consenting Pediatric Populations
59
Based on age Between
7 and 18
Reminder! • Different ages of majority
• Whenever a participant turns the age of
majority during a study that participant
must be consented with the consent form
Assent requirements
Based on age Between
7 and 18
Option 3: Assent form
7-15; or assent forms 7-
11 and 12-15; and
consent/assent form for
participants 16-18 • means the consent form is
written at a level in which a 16
year old could understand and
means that the participant will
provide their written assent on
the actual consent form after
their parent/guardian’s consent
signature
Consenting Pediatric Populations
60
Reminder! • Different ages of majority
• Whenever a participant turns the age of
majority during a study that participant
must be consented with the consent form
Assent requirements
The IRB can always waive assent altogether for all
participants if the following criteria are satisfied:
• The clinical investigation involves no more than minimal
risk to the subjects;
• The waiver will not adversely affect the rights and welfare
of the subjects;
• The clinical investigation could not practicably be carried
out without the waiver; and
• Whenever appropriate, the subjects will be provided with
additional pertinent information after participation
Consenting Pediatric Populations
61
Waiving Assent no matter the age, maturity, or psychological state
45 CFR 46.408(a)
Conducting Research in Pediatric Populations
Must the child be provided with the assent form for participants 7-
11 years old and provide her assent in order to remain in the trial?
An IRB reviewing a non-Hodgkin’s lymphoma oncology clinical trial (with
the potential for direct benefit) waived the requirement for assent for those
participants under the age of seven. A six-year-old child with non-
Hodgkin’s lymphoma is enrolled in the trial. After three months in the trial,
the child has her seventh birthday.
62
Testing Our Knowledge
Conducting Research in Pediatric Populations
Must the child be provided with the assent form for participants 7-
11 years old and provide her assent in order to remain in the trial?
An IRB reviewing a non-Hodgkin’s lymphoma oncology clinical trial (with
the potential for direct benefit) waived the requirement for assent for those
participants under the age of seven. A six-year-old child with non-
Hodgkin’s lymphoma is enrolled in the trial. After three months in the trial,
the child has her seventh birthday.
63
Testing Our Knowledge
NO
Conducting Research in Pediatric Populations
In order to approve Pediatric research that is permitted under the regulations an IRB must ensure . . .
• risks to participants are minimized
• risk to benefit ratio is acceptable
• selection of participants is equitable
• informed consent and assent will be sought and documented
• adequate safety monitoring is in place
• adequate privacy protections are in place
• additional safeguards are in place to protect the rights and welfare of participants
Conducting Research in Pediatric Populations
21 CFR 56.111 and 45 CFR 46.111
65
In order to approve Pediatric research that is permitted under the regulations an IRB must ensure . . .
• risks to participants are minimized
• risk to benefit ratio is acceptable
• selection of participants is equitable
• informed consent and assent will be sought and documented
• adequate safety monitoring is in place
• adequate privacy protections are in place
• additional safeguards are in place to protect the rights and welfare of participants
Conducting Research in Pediatric Populations
21 CFR 56.111 and 45 CFR 46.111
66
In order to approve Pediatric research that is permitted under the regulations an IRB must ensure . . .
• risks to participants are minimized
• risk to benefit ratio is acceptable
• selection of participants is equitable
• informed consent and assent will be sought and documented
• adequate safety monitoring is in place
• adequate privacy protections are in place
• additional safeguards are in place to protect the rights and welfare of participants
Conducting Research in Pediatric Populations
21 CFR 56.111 and 45 CFR 46.111
67
Minimizing Risks To Participants To help understand what it means to minimize risks to children evaluate risks from the perspective of a child:
• Medical facilities are scary and cause distress Conduct the research in a child friendly atmosphere to reduce distress ex. play equipment, furniture, age appropriate food, activities
• Medical procedures hurt Use procedures to reduce pain ex. topical anesthesia to place IV catheters, indwelling catheters rather than repeated venipunctures for blood sampling
• More procedures equal more distress and more pain Be efficient to reduce distress and pain
ex. if possible, conduct interventions at the same time clinically indicated interventions are scheduled; utilize staff that is experienced working with children to ensure they are skilled and quick at administering procedures, such as blood draws
68
Conducting Research in Pediatric Populations
Minimizing Risks To Participants To help understand what it means to minimize risks to children, evaluate the protocol and consent process specifically for children
• Minimize risks to children by tailoring the consent process to children Design the consent and assent process to ensure comprehension, appropriate parental/guardian involvement, and privacy issues
• Ex. Assent forms written at the appropriate reading level
• Ex. Inclusion of graphs, charts, or visuals incorporated into the assent discussion
• Ex. Separate discussions with children and their parents as necessary
• Minimize risks to children by scientifically evaluating risks Design protocols to protect against adverse outcomes that generally only affect minors
• Ex. impairments of cognitive growth or skeletal development
• Ex. reduce the overall amount of blood required for the study by using sensitive assays, pediatric-enabled laboratories, and population pharmacokinetic approaches
69
Conducting Research in Pediatric Populations
The IRB determines an
appropriate blood draw volume
taking into account the following
Blood Draw Volumes in Children
• Type of research in which the child is enrolled
• Severity of the child’s condition
• Hemoglobin levels
• Frequency of blood draws
• Collection procedure
• Age of population
• Protocol justification for the volume
Conducting Research in Pediatric Populations
70
Ex. Various Children’s Hospitals throughout
the United States follow these
recommendations:
Maximum Allowable Blood Draw Volumes
(Clinical + Research)
Maximum of 2.5% of total blood volume in one
blood draw and a maximum of 5.0% of total
blood volume in a 30 day period.
www.seattlechildrens.org/pdf/blood-volume-chart.pdf
Conducting Research in Pediatric Populations
Is the potential blood collection volume acceptable?
A study in children involves several blood draws over the course of 30
days. The target total amount of blood drawn within that time is 5% of a
participant’s blood volume. The protocol for the study notes that a blood
draw may have to be repeated in the event that a child’s blood sample is
contaminated in the laboratory.
71
Testing Our Knowledge
Conducting Research in Pediatric Populations
Is the potential blood collection volume acceptable?
A study in children involves several blood draws over the course of 30
days. The target total amount of blood drawn within that time is 5% of a
participant’s blood volume. The protocol for the study notes that a blood
draw may have to be repeated in the event that a child’s blood sample is
contaminated in the laboratory.
72
Testing Our Knowledge
NO
• Require that each Investigator has
the appropriate training and
expertise in pediatric populations
(i.e. use a pediatrician, pediatric
oncologist, pediatric cardiologist,
etc.)
• More frequent DSMB meetings
• Omit any discussion of
compensation from the assent
discussion
• Develop documents to periodically
check a child’s willingness to
continue in the research (remember,
assent is an active and ongoing
process!)
73
Conducting Research in Pediatric Populations
Additional Safeguards
First, one additional safeguard is
ensuring the protocol fits into one of
the categories of research in children.
Remember, the IRB cannot approve
the research unless it fits into one of
the four applicable regulatory
categories
Second, other examples include:
Key Take Aways
• Research in children is important and know how to protect the rights, safety, and welfare of these young participants
• The key regulatory documents are 21 CFR 50, Subpart D; 45 CFR 46, Subpart D; and in Canada ICH-E11
• The IRB can only approve research in children that falls into one of four categories and these categories also tell us whether the consent of one or both parents/guardians is required
• Tailor advertisements appropriately to children when they are your audience
• Permission and assent are required in order to enroll children into research and understand how to obtain and document both
• Always ensure the research minimizes risks to children and includes additional safeguards
Key Take Aways
75
Additional Questions
• You may submit questions during our webinar
survey, or
• You may email your questions to:
• We will do our best to follow-up individually or
answer your questions in the Q&A we post on
our website
76
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SURVEY and provide us with feedback
77
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78
Thank You for Attending!
79
fully accredited since 2006
Navigating Research in Pediatric Populations